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Abstract:

A color-coded bioprosthetic valve system having a valve with an annular
sewing ring, and a valve holder system with a holder sutured to the ring
of the valve, a post operatively connected to the holder, and an adapter
sutured to the post and having a color associated with the valve model
and/or size. For example, the adapter may be blue to indicate that the
valve of the system is a mitral valve of a particular type and/or size.
The system may also include a flex handle that is configured to engage
with the adapter. The handle has a color associated with the adapter such
that a user is able to visually determine that the handle color matches
the valve model. For example, the handle may have a grip that is colored
blue to match the blue color of the adapter. Accordingly, the color-coded
system enables users to confirm easily that the correct accessories such
as the sizer or flex handle are being used with the correct valve.

Claims:

1. A color-coded prosthetic heart valve system comprising: a heart valve
of a labeled size; and a heart valve holder system having a stationary
part in a first color attachable to the heart valve and having at least
two movable parts that are movable with respect to the stationary part in
a second color distinct from the first color.

2. The heart valve system of claim 1, wherein the heart valve includes a
stent on an inflow end, flexible commissures projecting from the stent in
an outflow direction, and flexible leaflets distributed about a valve
axis and supported between the flexible commissures, the stationary part
comprises a holder attached to an inflow side of the valve, and one of
the two movable parts comprises a proximal end of a post that translates
along the valve axis with respect to the holder and passes through a
central bore in the holder, wherein the heart valve holder system further
including filaments that are attached to the holder and extend through
the heart valve and cross over between tips of the flexible commissures,
and wherein a distal end of the post contacts the filaments along the
valve axis so as to push them in a distal direction and flex the
commissure tips inward.

3. The heart valve system of claim 2, wherein the holder is sutured to a
sewing ring on an inflow side of the valve, and the proximal end of the
post comprises an adapter sutured to the post, the adapter having the
second color.

4. The heart valve system of claim 3, wherein the holder, the post, and
the adapter each have a color that is in contrast to one another such
that the holder is visually distinguishable from the post and the
adapter, and the post is visually distinguishable from the adapter.

5. The heart valve system of claim 1, wherein one of the two movable
parts comprises a flex handle configured to engage with the other movable
part of the valve holder system, wherein a grip of the flex handle is in
the second color.

6. The heart valve system of claim 1, wherein the valve holder system
further includes a jar clip in a third color to which the stationary part
is operatively removable for protection within a storage jar, the jar
clip having a movement indicator thereon in the second color that
indicates the direction of movement of the movable part relative to the
stationary part.

7. The heart valve system of claim 1, further including an annulus sizer
having a grip in the second color, the second color being associated with
the labeled valve size.

8. A color-coded prosthetic heart valve system comprising: a heart valve
of a labeled size; and a heart valve holder system attachable to the
heart valve having a first stationary part in a first color and a first
movable part that is movable with respect to the stationary part in a
second color distinct from the first color, and a second stationary part
including a movement indicator thereon in the second color that indicates
the direction of movement of the first movable part relative to the
second stationary part.

9. The heart valve system of claim 8, wherein the heart valve includes a
stent on an inflow end, flexible commissures projecting from the stent in
an outflow direction, and flexible leaflets distributed about a valve
axis and supported between the flexible commissures, the first stationary
part comprises a holder attached to an inflow side of the valve, wherein
the heart valve holder system further including filaments that are
attached to the holder and extend through the heart valve and cross over
between tips of the flexible commissures, and wherein the first movable
part comprises a proximal end of a post that first rotates about and then
translates along the valve axis with respect to the holder and passes
through a central bore in the holder, and wherein a distal end of the
post contacts the filaments along the valve axis so as to push them in a
distal direction and flex the commissure tips inward, the movement
indicator showing the direction to rotate the post to enable it to
translate along the valve axis.

10. The heart valve system of claim 9, wherein the holder is sutured to a
sewing ring on an inflow side of the valve, and the proximal end of the
post comprises an adapter sutured to the post, the adapter having the
second color.

11. The heart valve system of claim 10, wherein the holder, the post, and
the adapter each have a color that is in contrast to one another such
that the holder is visually distinguishable from the post and the
adapter, and the post is visually distinguishable from the adapter.

12. The heart valve system of claim 8, wherein a second movable part in
the second color comprises a flex handle configured to engage with the
first movable part of the valve holder system, wherein a grip of the flex
handle is in the second color.

13. The heart valve system of claim 8, wherein the second stationary part
comprises a jar clip in a third color to which the first stationary part
is operatively removable for protection within a storage jar.

14. The heart valve system of claim 8, further including an annulus sizer
having a grip in the second color, the second color being associated with
the labeled valve size.

15. A method of deploying a heart valve system, comprising: obtaining a
color-coded prosthetic heart valve system comprising: a heart valve of a
labeled size including a stent on an inflow end, flexible commissures
projecting from the stent in an outflow direction, and flexible leaflets
distributed about a valve axis and supported between the flexible
commissures; and a heart valve holder system attachable to the heart
valve having a holder attached to an inflow side of the valve in a first
color, a first movable part that is movable with respect to the holder in
a second color distinct from the first color, and a second stationary
part including a movement indicator thereon in the second color that
indicates the direction of movement of the first movable part relative to
the second stationary part, displacing the first movable part as
indicated by the movement indicator and causing the first movable part to
flex tips of the valve commissures inward.

16. The method of claim 15, wherein the heart valve holder system further
includes filaments that are attached to the holder and extend through the
heart valve and cross over between tips of the flexible commissures, and
wherein the first movable part comprises a proximal end of a post that
first rotates about and then translates along the valve axis with respect
to the holder and passes through a central bore in the holder, and
wherein a distal end of the post contacts the filaments along the valve
axis so as to push them in a distal direction and flex the commissure
tips inward, the movement indicator showing the direction to rotate the
post to enable it to translate along the valve axis.

17. The method of claim 15, wherein a second movable part in the second
color comprises a flex handle configured to engage with the first movable
part of the valve holder system, wherein a grip of the flex handle is in
the second color, and further comprising screwing the handle into the
first movable part and using the handle to displace the first movable
part.

18. The method of claim 17, wherein the first movable part comprises a
proximal end of a post that first rotates about and then translates along
the valve axis with respect to the holder and passes through a central
bore in the holder, the method including fully screwing the flex handle
into the proximal end of the post and then further rotating the flex
handle as indicated by the movement indicator, thereby also rotating the
post until the post can be translated axially.

19. The method of claim 18, wherein the proximal end of the post
comprises an adapter sutured to the post, the adapter having the second
color, the method including severing sutures connecting the adapter to
the post and detaching the adapter and flex handle from the post.

20. The method of claim 19, wherein the flex holder, the post, and the
adapter each have a color that is in contrast to one another such that
the holder is visually distinguishable from the post and the adapter, and
the post is visually distinguishable from the adapter.

[0003] The most common flexible leaflet valve construction includes three
leaflets mounted to commissure posts around a peripheral non-expandable
support structure with free edges that project toward an outflow
direction and meet or coapt in the middle of the flowstream. A
suture-permeable sewing ring is provided around the inflow end.

[0004] The most successful bioprosthetic materials for flexible leaflets
are whole porcine valves and separate leaflets made from bovine
pericardium stitched together to form a tri-leaflet valve. Bioprosthetic
heart valves are packaged in jars filled with preserving solution for
shipping and storage prior to use in the operating theater. To minimize
the possibility of damage to the relatively delicate bioprosthetic heart
valves, they are stabilized with bracketing structure to prevent them
from striking the inside of the jar. The valves are stabilized with
various structures, including a 2- or 3-piece clip and tubular sleeve
structure, such as shown in U.S. Pat. No. 6,416,547 to Erickson, et al.

[0005] Bioprosthetic valves typically have a delivery holder centrally
located and sutured thereto, and an elongated delivery handle couples to
the holder for manipulating the valve assembly during implant. The holder
is attached to the inflow sewing ring for mitral valves and to the inflow
cusps or outflow commissure tips for aortic valves.

[0006] Mitral valve replacement is the most common when moderate to severe
calcification is present on the leaflets. When implanting a valve in the
mitral position the valve is inverted with the inflow side facing the
surgeon. Due to this less visible and somewhat difficult implant
configuration, ease of the implant and suturing procedure is more
important.

[0007] When placing a tissue type prosthetic valve in the mitral position,
the commissure posts are on the distal or blind side of the valve and may
become entangled with pre-installed anchoring sutures, potentially
damaging the annulus or tissue valve during delivery. Some attempts have
been made to overcome these problems in current holders for prosthetic
mitral valves. An example of such a holder is U.S. Pat. No. 4,865,600,
Carpentier, et al., incorporated herein by reference, and another similar
device is seen in U.S. Pat. No. 6,966,925 to Stobie which includes a
shaft member positioned on the holder that is axially movable just prior
to valve deployment to cause lengths of holder-valve attachment sutures
to extend axially beyond the commissure posts in the fashion of a tent,
thereby preventing looping of an array of pre-implanted anchoring sutures
around the commissure posts.

[0008] Because of the complexity of certain bioprosthetic valve systems,
there is a continued need in the art for enhancements to ease the use of
such systems for the operating room staff and surgeon.

SUMMARY OF THE INVENTION

[0009] According to one aspect of the invention, a color-coded
bioprosthetic valve system may include a bioprosthetic valve and a valve
holder system. Color coding facilitates training of O.R. staff in
procedural steps and correct identification of components used in a
valve/accessory system.

[0010] The valve typically has an internal stent and an annular sewing
ring on an inflow end, and is of a particular valve model, such as a
mitral valve of a labeled size. The valve holder system may include a
holder sutured to the ring of the valve, a post operatively connected to
the holder, and an adapter sutured to the post and having a color
associated with the valve model. For example, the adapter may be blue to
indicate that the valve of the system is a mitral valve. The system may
also include a flex handle that engages with the adapter. The handle has
a color associated with the adapter such that a user is able to visually
determine that the handle color matches the valve model. For example, the
handle may have a grip that is colored blue to match the blue color of
the adapter. Accordingly, the color-coded system enables users to confirm
easily that the correct accessories such as the sizer or flex handle are
being used with the correct valve.

[0011] According to another aspect, the holder, the post, and the adapter
may each have a color that is in contrast to each other such that the
holder is visually distinguishable from the post and the adapter, and the
post is visually distinguishable from the adapter. This color contrast
may aid a user to confirm that proper deployment has been obtained. For
example, the holder may be grey, the post white, and the adapter blue,
and proper deployment may be confirmed by inspecting that the white post
or blue adapter abuts or is flush with the gray holder.

[0012] The Magna Mitral Ease from Edwards Lifesciences is one particular
heart valve that includes various design features for easier
implantation. For example, the valve system includes a tri-colored holder
and a unique suture guide line, as described herein, and a wide,
saddle-shaped cuff. This new mitral bovine pericardial heart valve also
features a holder that makes an audible click to indicate the valve has
been properly rotated and set into place. However, it is the color visual
cues with easy-to-follow instructions on the quick reference card which
makes procedure preparation extremely straightforward.

[0013] In a preferred embodiment, a color-coded prosthetic heart valve
system comprises a heart valve of a labeled size, and a heart valve
holder system. The holder system has a stationary part in a first color
attachable to the heart valve and having at least two movable parts that
are movable with respect to the stationary part in a second color
distinct from the first color. One of the two movable parts may comprise
a flex handle that engages with the other movable part of the valve
holder system, wherein a grip of the flex handle is in the second color.
The valve holder system may further include a jar clip in a third color
to which the stationary part is operatively removable for protection
within a storage jar, the jar clip having a movement indicator thereon in
the second color that indicates the direction of movement of the movable
part relative to the stationary part. The heart valve system desirably
also has an annulus sizer having a grip in the second color, the second
color being associated with the labeled valve size.

[0014] The heart valve may include a stent on an inflow end, flexible
commissures projecting from the stent in an outflow direction, and
flexible leaflets distributed about a valve axis and supported between
the flexible commissures. The stationary part preferably comprises a
holder attached to an inflow side of the valve, and one of the two
movable parts comprises a proximal end of a post that translates along
the valve axis with respect to the holder and passes through a central
bore in the holder. The heart valve holder system further including
filaments that are attached to the holder and extend through the heart
valve and cross over between tips of the flexible commissures, wherein a
distal end of the post contacts the filaments along the valve axis so as
to push them in a distal direction and flex the commissure tips inward.
The holder is desirably sutured to a sewing ring on an inflow side of the
valve, and the proximal end of the post comprises an adapter sutured to
the post, the adapter having the second color. Preferably, the holder,
the post, and the adapter each have a color that is in contrast to one
another such that the holder is visually distinguishable from the post
and the adapter, and the post is visually distinguishable from the
adapter.

[0015] Another color-coded prosthetic heart valve system comprises a heart
valve of a labeled size, and a heart valve holder system attachable to
the heart valve. The holder system includes a first stationary part in a
first color and a first movable part that is movable with respect to the
stationary part in a second color distinct from the first color, and a
second stationary part including a movement indicator thereon in the
second color that indicates the direction of movement of the first
movable part relative to the second stationary part. A second movable
part in the second color preferably comprises a flex handle that engages
with the first movable part of the valve holder system, wherein a grip of
the flex handle is in the second color. The second stationary part may be
a jar clip in a third color to which the first stationary part is
operatively removable for protection within a storage jar. In a preferred
embodiment, the heart valve system further includes an annulus sizer
having a grip in the second color, the second color being associated with
the labeled valve size.

[0016] The heart valve may include a stent on an inflow end, flexible
commissures projecting from the stent in an outflow direction, and
flexible leaflets distributed about a valve axis and supported between
the flexible commissures. The first stationary part desirably comprises a
holder attached to an inflow side of the valve, wherein the heart valve
holder system further including filaments that are attached to the holder
and extend through the heart valve and cross over between tips of the
flexible commissures. Further, the first movable part preferably
comprises a proximal end of a post that first rotates about and then
translates along the valve axis with respect to the holder and passes
through a central bore in the holder. A distal end of the post contacts
the filaments along the valve axis so as to push them in a distal
direction and flex the commissure tips inward, the movement indicator
showing the direction to rotate the post to enable it to translate along
the valve axis. The holder may be sutured to a sewing ring on an inflow
side of the valve, and the proximal end of the post may comprise an
adapter sutured to the post, the adapter having the second color.
Preferably, the holder, the post, and the adapter each have a color that
is in contrast to one another such that the holder is visually
distinguishable from the post and the adapter, and the post is visually
distinguishable from the adapter.

[0017] A method of deploying a heart valve system is also provided
including first obtaining a color-coded prosthetic heart valve system,
the system comprising: [0018] a heart valve of a labeled size including
a stent on an inflow end, flexible commissures projecting from the stent
in an outflow direction, and flexible leaflets distributed about a valve
axis and supported between the flexible commissures; and [0019] a heart
valve holder system attachable to the heart valve having a holder
attached to an inflow side of the valve in a first color, a first movable
part that is movable with respect to the holder in a second color
distinct from the first color, and a second stationary part including a
movement indicator thereon in the second color that indicates the
direction of movement of the first movable part relative to the second
stationary part,

[0020] The method includes displacing the first movable part as indicated
by the movement indicator and causing the first movable part to flex tips
of the valve commissures inward. The heart valve holder system desirably
includes filaments that are attached to the holder and extend through the
heart valve and cross over between tips of the flexible commissures. The
first movable part may be a proximal end of a post that first rotates
about and then translates along the valve axis with respect to the holder
and passes through a central bore in the holder, wherein a distal end of
the post contacts the filaments along the valve axis so as to push them
in a distal direction and flex the commissure tips inward, the movement
indicator showing the direction to rotate the post to enable it to
translate along the valve axis. Desirably, a second movable part in the
second color comprises a flex handle that engages with the first movable
part of the valve holder system, wherein a grip of the flex handle is in
the second color, and the method further comprises screwing the handle
into the first movable part and using the handle to displace the first
movable part. The first movable part may comprise a proximal end of a
post that first rotates about and then translates along the valve axis
with respect to the holder and passes through a central bore in the
holder. The method therefore includes fully screwing the flex handle into
the proximal end of the post and then further rotating the flex handle as
indicated by the movement indicator, thereby also rotating the post until
the post can be translated axially. In one embodiment, the proximal end
of the post comprises an adapter sutured to the post, the adapter having
the second color, the method including severing sutures connecting the
adapter to the post and detaching the adapter and flex handle from the
post.

[0021] Furthermore, the flex holder, the post, and the adapter each may
have a color that is in contrast to one another such that the holder is
visually distinguishable from the post and the adapter, and the post is
visually distinguishable from the adapter.

[0022] A further understanding of the nature and advantages of the
invention will become apparent by reference to the remaining portions of
the specification and drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Features and advantages of the present invention will become
appreciated as the same become better understood with reference to the
specification, claims, and appended drawings wherein:

[0024]FIG. 1 illustrates a system for heart valve replacement according
to a number of embodiments;

[0025] FIG. 2 illustrates a color-coded flex handle according to still
other embodiments, including, for example, a blue grip;

[0026]FIG. 3 illustrates a color-coded valve annulus sizer according to
other embodiments, including, for example, a blue grip;

[0027]FIG. 4 illustrates a bioprosthetic valve with a color-coded clip
and arrow indicia according to some of the embodiments;

[0028]FIG. 5 illustrates a bioprosthetic valve with a color-coded system
including a blue adapter and grey holder;

[0030] FIG. 7 illustrates a color-coded assembly shown in an undeployed
position according to a number of embodiments and including a distal
portion of a flex handle connected to a bioprosthetic valve, particularly
including, for example, an adapter with blue coding, a post with white
coding, and a holder with gray coding;

[0031]FIG. 8 illustrates the assembly of FIG. 7 in a deployed position,
enabling user confirmation of proper deployment, for example, by
inspection that the blue-coded adapter is flush with the gray-colored
holder;

[0032]FIG. 9 is a perspective view of the deployed assembly of FIG. 8,
particularly illustrating the flex handle having molded grip with blue
coding that matches the blue coding of the adapter, thereby enabling easy
user confirmation that this particular flex handle is being properly used
with this particular valve model;

[0033] FIGS. 10A, 10B, and 10C illustrate a color-coded assembly according
to still other embodiments, respectively showing sequential stages of a
valve subassembly with holder system being unlocked and deployed,
particularly illustrating a blue-coded arrow indicia on the clip
indicating to a user a direction that a blue-coded flex handle should be
rotated so that a blue-coded adapter rotates in the proper direction for
unlocking; and

[0034]FIG. 11 illustrates a reference card according to a number of
embodiments, showing, for example, the steps for proper deployment of a
valve subassembly.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0035] Referring to the drawings in detail, a color-coded bioprosthetic
mitral valve and holder system is shown in FIGS. 1-3 according to a
number of embodiments. The system may include a prosthetic valve 20 and a
valve holder system 22. The valve 20 has a labeled size (typically
between 25 and 33 mm in 2 mm increments) and is of a particular valve
model, such as a mitral valve of a particular type (e.g., the Magna
Mitral Ease system available from Edwards Lifesciences of Irvine,
Calif.). The valve 20 has an annular sewing ring 24 on an inflow end, an
internal stent (not shown) with generally axially-directed commissures 26
projecting in an outflow direction, and a plurality of flexible leaflets
28 distributed about a central valve axis and supported by the
commissures, thus providing occluding surfaces within the valve orifice.

[0036] The valve holder system 22 may include a holder 30 sutured to the
sewing ring 24 of the valve, a post 32 operatively connected to the
holder, and an adapter 34 sutured to the post and having a color
associated with the valve model and/or size. For example, in some of the
embodiments, the adapter may be blue to indicate that the valve of the
system is a Magna Mitral Ease valve. Additionally, shades of one color,
different colors, or colors with distinctive cross-hatching, for
instance, may be used to distinguish valves of different sizes within a
line of valves. The holder attaches to a clip 36 which couples to a
ribbed sleeve 38 to protect the valve from damage inside a storage jar
(see 35 in FIG. 4). Greater details of such a holder and storage system
can be found in U.S. Pat. No. 6,966,925 to Stobie, which disclosure is
expressly incorporated herein.

[0037] The system may also include a flex handle 40 as shown in FIG. 2
that engages with the adapter 34 on the proximal end of post 32.
According to a number of embodiments, the handle 40 has a color
associated with the adapter 34 such that a user is able to visually
determine that the handle color matches the valve model and/or size. For
example, as shown particularly in FIG. 2, the handle 40 may have a grip
42 that is a color such as blue to match the blue color of the adapter
34. Accordingly, the color-coded system enables users to confirm easily
that the correct accessories (such as a sizer in FIG. 3) or the correct
valve is being used with the handle, which is also shown in FIG. 9. (It
should be noted that since color cannot usually be shown in patent
drawings, different colors are indicated with particular shading as set
forth in the Patent Office drawing guidelines, MPEP §608.02).

[0038] In additional embodiments such as shown in FIGS. 1 and 4, the valve
holder system 22 may also include a clip 36 from which the holder 30 is
operatively removable. The clip 36 may have colored movement indicia 44
such as an arrow indicating to a user a direction to rotate the handle 40
to engage with the adapter 34, and for actuating a valve commissure
constriction mechanism as will be explained.

[0039] The components shown in FIG. 1 are assembled together in a valve
jar. When the nurse or technician opens the jar, they must perform the
following steps, as seen in FIGS. 10A-10C, to deploy the holder system
prior to handing the valve off to the surgeon for implantation: [0040]
a. Screw handle into the Adapter until handle is fully engaged. [0041] b.
Continue to rotate handle clockwise until the Adapter & Post unlocks in
the Holder. [0042] c. Pull the assembly (Valve, Clip, Holder, Post, and
Adapter) from the jar. [0043] d. Push the Post through the Holder to
deploy the holder system.

[0044] While the surgeon is implanting the valve, several steps he/she
performs are: [0045] a. To remove the Adapter/Handle: cut the attached
suture thread and pull off the Adapter/Handle. [0046] b. To remove the
Holder/Post from the Valve: cut the three attached suture threads and
pull off the Holder/Post.

[0047] In the illustrated embodiment, the adapter 34 attaches with sutures
to the proximal end of the post 32, and can be severed and removed
therefrom while the post remains locked in the position constricting the
valve commissures. This enables the handle 40 to be easily removed
without having to unscrew it. However, the adapter 34 may be eliminated
such that the distal end of the handle 40 engages the proximal end of the
post 32 directly, which would then be also colored blue. In terms of the
user, the colored-coded "proximal end of the post" is therefore either
the post 32 or the adapter 34 thereon.

[0048] To deploy the holder system such that the valve commissures 26
constrict, the post 32 translates through the valve orifice, as seen in
FIGS. 7 and 8. More particularly, the holder 30 attaches to the inflow
side of the valve 20 and is thus stationary. The holder as seen in FIG. 1
has a central bore. The post 32 translates along the valve axis with
respect to the holder 30 and passes through the central bore therein. The
heart valve holder system further including filaments 46 that are
attached to the holder 30, extending through the heart valve 20 and
crossing over along the central valve axis between tips of the flexible
commissures 26. The distal end of the post 32 eventually contacts the
filaments 46 along the valve axis so as to push them in a distal
direction and flex the commissure tips inward. It should be understood
that this is just one embodiment of commissure constriction, and other
mechanisms with relatively moving parts may benefit from being
color-coded. Furthermore, other mechanisms for manipulating the valve or
holder, or that simply facilitate manual handling of the holder system
and valve may benefit from a color-coding system as described herein.

[0049] In still other embodiments such as shown in FIGS. 1, 5, 7 and 8,
the holder 30, the post 32, and the adapter 34 may each have a color that
is in contrast to each other such that the holder is visually
distinguishable from the post and the adapter, and the post is visually
distinguishable from the adapter. For instance, the stationary holder 30
may be a first color (e.g., grey) and the adapter 34 (or proximal end of
the post 32) is a second, distinct color (e.g., blue). Further, the post
32 may be a third color (e.g., white) distinct from the first and second
colors. Also, it should be noted that the post 32 and adapter 34 are
movable with respect to the holder 30, which in turn is fixed to the
valve 20, so there are distinct colors for relatively movable parts.

[0050] As particularly shown in FIG. 8, this color contrast may aid a user
to confirm that proper deployment has been obtained, by inspecting that
the white post 32 or blue adapter 34 abuts or is flush with the gray
holder 30. A further aid may be provided in the form of instructions that
refer not just to the relatively movable parts but also to their
respective colors (see below). Since the user views the assembly from the
top, as in FIG. 4, it is difficult to see the white post 32 from this
perspective because of the blue adapter 34 on its proximal end. So the
user should look for the blue adapter 34 to be flush with the top of the
gray holder 30 (there are two wings slightly raised on the top of the
holder, and the top of the blue adapter is generally at the same level as
the top of the two wings of the holder).

[0051] In further embodiments as shown in FIGS. 6A and 6B, the valve 20
may include an annular sewing ring 24 with indicia for indicating suture
placement. For example, as shown in FIG. 6A, the indicia may include a
single guideline 50 disposed on the annular ring to indicate the desired
suture location. Alternatively, as shown in FIG. 6B, the indicia may
include a pair of concentric guidelines 52 disposed on the annular ring
24 to indicate boundaries of an acceptable suture zone.

[0052] To use the valve system, the flex handle 40 may be screwed into the
adapter 34 as shown in FIG. 10A. The blue arrow movement indicator 44 of
the clip 36 indicate to the user to rotate the handle 40 clockwise as
shown for engagement, which is also shown in FIG. 4. The handle 40 may be
continued to be rotated as indicated by the blue arrow indicia of the
clip 36, thereby also rotating the adapter 34 and the post 32 until the
post unlocks in the holder as shown in FIG. 10B. That is, the post 32 is
prevented from translating axially until it has been rotated a certain
angular extent. The handle 40 may then be urged toward the holder 30 as
shown by the arrow in FIG. 10c, thereby urging the post 32 through the
holder 30 until it is fully seated in the holder, thereby deploying the
valve holder system as shown in FIG. 8.

[0053] According to additional embodiments, the system may also include a
deployment quick reference card 60 as shown in FIG. 11 to aid the user in
performing these operations. The reference card may provide instructions
by indicating to colors of, for example, the adapter, the post, the
holder, rather than specific names of such elements, to further
facilitate the easy use of the system.

[0054] To further utilize the system, the suture thread connecting the
adapter to the holder as shown in FIGS. 4 and 5 may be cut to remove the
handle and the adapter from the holder. In addition, the suture thread
connecting the holder to the annular ring of the valve, as particularly
shown in FIG. 5, may be cut to remove the holder and the post from the
valve.

[0055] In view of the foregoing description, the color-coded system eases
training and provides intuitive deployment for the operating room staff
and surgeon. The multi-color delivery system may incorporate color
schemes among the features of the valve, the holder, accessories, and
packaging to clearly indicate complementary parts. At the same time,
contrasting color schemes increase visibility of separate components. In
addition, color coding facilitates operating training as the instruction
card may refer to parts and features in terms of color, rather than using
terms unfamiliar to the user or longer descriptions of component features
or geometry.

[0056] Color coding the different components may improve training in the
following areas:

[0057] 1. O.R. Staff: [0058] Matching components/accessories with the
correct valve/accessory system. For example, the Magna Mitral Ease system
available from Edwards Lifesciences of Irvine, Calif. is characterized by
the blue color of the accessory handles, the blue Adapter, and the blue
arrow on the Clip. Other valve/accessories may use another color for
differentiation. [0059] Ease in learning and remembering the different
components in the holder system for deployment. For example, components
are referred to in terms of part name AND color rather than just
potentially unfamiliar phrases such as "Holder", "Post", "Adapter", etc.
This improves clarity when training users as familiar colors would be
easy to refer to when training and easy to remember when referring to a
reference card as shown in FIG. 11. [0060] Ease in learning, remembering,
and confirming holder system steps. For example, color coding can clarify
directional information for actions required. The blue arrow on the Clip
pointed in the clockwise direction highlights the fact that the user must
turn the blue Handle and the blue Adapter in the clockwise direction.
Another example is that the user must perform a visual inspection to
confirm an action--be sure that the blue part (Adapter) is flush with the
gray part (Holder). Additionally color contrast between components may
provide additional visual cues into how each part interacts with other
parts, defining extent and fit of each part into one another and making
apparent each component's function.

[0061] 2. Surgeons: [0062] Ease in identifying the correct suture
threads to cut to release the Adapter/Handle, or the Holder/Post. For
example, the surgeon could be told to cut the suture on the blue part
first (i.e. Adapter) to remove the Handle (and not to cut the suture on
the gray part, i.e. Holder).

[0063] While the foregoing is a complete description of the preferred
embodiments of the invention, various alternatives, modifications, and
equivalents may be used. Moreover, it will be obvious that certain other
modifications may be practiced within the scope of the appended claims.